BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENT

    MDR report key: 24055725 · Received January 13, 2026

    Report

    Report Number
    1038671-2026-00043
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    August 1, 2018
    Report Date
    January 13, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE: 2954361. 300-01-15 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM: 2961376. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 2880614. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 2750578. 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 2769263. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: 2866615. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: 2739800. 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 2897443. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 4 YEAR(S) AND 9 MONTH(S) POST IMPLANTATION OF A RIGHT TSA, THE PATIENT PRESENTED WITH INFECTION. THE PATIENT HAD RTSA WITH LOOSE GLENOSPHERE + METAGLENE COMPONENT WITHOUT BROKEN HARDWARE AND SCAPULAR NOTCHING. PLAN FOR REVISION WITH ANTIBIOTIC SPACER. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION IN EARLY 2019 FOLLOWED WITH ANTIBIOTIC SPACER PROCEDURE LATER THAT YEAR. IMPLANTATION OF ANTIBIOTIC DELIVERY SYSTEM DUE TO POSITIVE MRSA SCREEN. PATIENT HAS CLEARED INFECTION AND DESIRES CONVERSION BACK TO A REVERSE TSA. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND UNLIKELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112494 EQUINOXE REVERSE SHOULDER COMPONENT SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male